Table 1.
Summary characteristics of published evidence relating to AZLI in CF patients
| Author | Pts | Design | Outcome |
|---|---|---|---|
| Gibson 200615 | 35 adults/adol FEV1 >40% | DB, placebo-controlled daily dose escalation study | Well tolerated, sputum levels >> MIC |
| Retsch-Bogart 200816 | 105 pts >13y, FEV1 >40 | DBRPCT 14d AZLI 75 or 225 mg vs placebo | No change FEV1 at d14 75 mg seems favoured |
| McCoy 200817 AIR-CF1 |
246 pts >5y, FEV1 25–75 Mean age 26.2y |
RDBPCT 28d AZLI 75 mg, bd or tds v placebo | Increased time to more antiPa abx, FEV1, symptom scores, Pa density |
| Retsch-Bogart 200918 AIR-CF2 |
164 pts >6y, FEV1 25–75 | RDBPCT 28d AZLI tds v placebo | Improved symptom scores CFQR, Pa density |
| Oermann 201019 | 274 pts >8y, from previous 2 studies | 18 m open label cyclical treatment bd or tds | Long term use well tolerated, cyclical improved FEV1, symptom scores, Pa density, wt |
| Wainwright 201120 | 157 pts, >5y, FEV1 >75% | RDBPCT 28d AZLI tds v placebo | No change symptom score, improved FEV1, Pa density |
RDBPCT – randomized double blind placebo controlled trial